TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1)— 510(k) K243956

Substantially Equivalent

Nihon Kohden Corporation

FDA 510(k) clearance K243956 for TG-980P CO2 Sensor Kit (TG-980P); TG-980P1 CO2 Sensor Kit (TG-980P1), Substantially Equivalent on 2025-06-10. Applicant: Nihon Kohden Corporation.

Clearance details

Applicant: Nihon Kohden Corporation
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 2024-12-23
Decision date: 2025-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tokyo, JP

Download summary PDF View on FDA.gov ↗

Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.